Events

Recall of Device Recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 2200 Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74647
  • Event Risk Class
    Class 2
  • Event Number
    Z-2847-2016
  • Event Initiated Date
    2016-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148844
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Reason
    The oral airway pouch within the pink/red oxygen delivery module, 7700raw, was incorrectly packaged with the 8 cm berman oral airway. the pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm berman oral airway component. therefore, the component within the pouch is incorrect. the pink/red oxygen delivery module, 7700raw, is intended to be used within the pink/red pouch of the broselow pediatric safety system. three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the pink/red oxygen delivery module, 7700raw, are affected by this voluntary field safety corrective action.
  • Action
    Recall notices were sent 6/29/2016.

Device

Device Recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM
  • Model / Serial
    Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 916714 of the Broselow Complete Set of Colored Pouches, Product Code 7730MOD. Expiration Date MAR 2018.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Illinois
  • Product Description
    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Manufacturer Address
    Carefusion 2200 Inc, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA